Placebos without deception: Misinformation that never dies

Since yesterday’s post about William Makis and “turbo cancer” appears to have gone over like the proverbial lead balloon, garnering exactly zero comments as of this writing, something that hasn’t happened in a very long time, I thought I’d move on to something that I haven’t discussed in a very long time—2016, as far as I can tell). (Maybe my readers are burned out on COVID-19 and antivax misinformation. I know that I am, at least a little bit.) Fortunately for a blogger looking for a different topic, The New York Times op-ed page yesterday served up a stinker of an article promoting a false narrative often used to justify alternative medicine and “integrating” quackery into medicine (“integrative medicine” or “integrative health”). It’s even by an old “friend” of the blog, an “integrative medicine” researcher and placebo promoter named Ted Kaptchuk, and the article promotes a very old quack narrative about placebos. However, since I haven’t written about this particular narrative about placebos in a long time, I thought that it would be worth applying a bit of the ol’ Insolence to the article, which is entitled No Better Than A Placebo.

Interestingly, the title shows up differently in different contexts. For example, one headline that I saw was Placebo Effect Is Powerful (which is more in keeping with Kaptchuk’s usual message and seen in some previews for social media), while another was Decongestant Placebo Medicine. The latter headline likely derives from the recent finding by the FDA that the decongestant phenylephrine is no more effective than placebo., a revelation that is actually not new news (we’ve known for at least 20 years that phenylephrine is pretty useless), but for some reason this year the FDA finally decided to weigh in. Likely a New York Times op-ed editor took note of these stories about phenylephrine and decided that now would be a good time to publish another credulous op-ed about the “power of placebos” to add to previous ones in 2021, 2018, and even earlier—back to at least 2010. Only this time, instead of just quoting Ted Kaptchuk, as is the NYT’s usual practice, they decided just to let him spin his tale however he wanted. And spin it he does!

First, Kaptchuk takes the recent stories about phenylephrine and uses them to introduce placebos in a manner that sets up his argument:

An advisory committee for the Food and Drug Administration recently concluded that a popular oral decongestant sold over the counter was no better than a placebo. The agency now faces the question of whether to pull medications that use the ingredient, phenylephrine, off store shelves.

The news spurred shock and anger over how long ineffective medicines have been for sale. But amid the criticism, there were also some who lamented the possibility that their favorite cold medicine would be taken from them. In their view, it may not work, but it still does something for them.

See where this is going? The exact same argument is often used to support alternative and “integrative” medicine modalities that are known to be completely ineffective, some of them (like homeopathy and reiki) being scientifically impossible; that is, unless huge swaths of long-understood and well-supported science are found not just to be wrong, but spectacularly wrong. The argument goes something like this; Sure, homeopathy and reiki do nothing that is distinguishable from placebo effect, but it’s the placebo effect—or, more properly, placebo effects—that matters. Reiki, homeopathy, acupuncture. However, all the other alternative medicine quackeries whose effects are indistinguishable from the nonspecific effects of placebos might not have specific effects that cure disease, but they’re “harnessing the power of placebos”—Deepak Chopra is particularly fond of this claim—and using the power of the mind to heal, all in order to do the patient good.

That background being established, Kaptchuk then appeals to authority, namely his authority, to assert without evidence that the placebo effect is “powerful” in some situations:

I’m a researcher who studies the placebo effect, and in some situations, it’s powerful. That said, oral phenylephrine sold over the counter should be removed from the market; despite some people’s love of phenylephrine cold medicines, there’s no evidence that the drug even provides placebo benefits. In clinical trials reviewed by the F.D.A. committee, phenylephrine and a placebo affected patients’ perceptions of nasal congestion equally, but the existing trials do not tell us to what extent people felt better because of placebo effects or because their colds simply resolved on their own.

Next up, Kaptchuk attacks what he sees as the key objection to “harnessing the power of placebos” without actually (yet) defining placebo effects. That objection is that you have to “lie to patients” by telling them that what you are giving them is effective, with the white coat of physician authority adding emphasis and credibility to the lie:

This controversy highlights the perplexing messages that imprison placebos in general. In research settings, placebo responses are powerful but a nuisance, as they make detecting a drug’s superiority over a placebo difficult. And in clinical practice they are powerful, but they often require deception, making them unethical. But can placebos ever come out of the shadows and become a legitimate component of health care? My research suggests so.

Longtime readers familiar with Ted Kaptchuk should have already guessed—and guessed accurately—where his placebo narrative in this op-ed is going. As I used to say a lot before the pandemic, before more general topics of alternative and “integrative” medicine were crowded out by COVID-19 conspiracy mongering and antivax misinformation, it is unethical to lie to patients. It is true that, say, 75 years ago it was considered much less unethical (or even ethical) to prescribe placebos. However, as I have also pointed out many times, that was an era in which medicine was much more paternalistic and it was considered acceptable for the physician to decide alone what was good for the patient. These days, the doctor-patient relationship, although by no means totally free of paternalism, is much more collaborative, and in general that’s a very good thing.

It is ironic how promoters of alternative medicine who argue for “harnessing the power of placebos” with woo like homeopathy, reiki, and acupuncture also often argue that they support “empowering” patients even as they support the more paternalistic model of healthcare in which they can tell patients that ineffective medicine is actually highly effective in order to “harness the power of the placebo effect.” Of course, they often don’t believe that quackery like homeopathy, reiki, and acupuncture are ineffective, but you get the idea.

Kaptchuk, being a Man of Science, bristles at such comparisons and supports the idea that is it unethical to deceive patients, even to “harness the power of placebo.” As a result, for a very long time he has been spinning a narrative about placebos that I like to call “placebos without deception.” This NYT op-ed is nothing more than that same narrative tarted up, updated, and spun based on recent news stories about the FDA conclusion about phenylephrine in order to resurrect it and make it seem new.

First, though, Kaptchuk defines placebo effects as “health improvements initiated from the rituals, symbols and behaviors involved with healing.” As Steve Novella notes, this is not quite right. A more accurate definition would be subjective improvements in symptoms initiated from the rituals, symbols and behaviors involved with healing or, as Dr. Novella phrases it, “apparent or measured ‘health improvements,’ if you include subjective symptoms as health improvements, which is reasonable but needs to be explicitly stated,” further noting that apparent “improvements may not be real” and “may entirely be illusions of how health outcomes are being measured.” Known phenomena that can contribute to placebo effects and be other reasons for apparent subjective improvements in health symptomatology include illusory effects like regression to the mean.

Then, no doubt Kaptchuk views his unleashing of his “science” and arguments the way Admiral Kirk viewed his upcoming counterattack in The Wrath of Khan, “Here it comes”:

Fifteen years ago, in the middle of my career as a placebo researcher, I had a crisis. My ultimate research goal had been to harness the power of placebo to relieve unnecessary suffering. But my early experiments always involved telling participants that they might receive or were receiving real medications when they were not. Placebos were tainted by trickery. I began to question the conventional dogma that placebos work only if patients don’t know they’re placebos. Could I instead be honest? My colleagues thought I was nuts.

I wonder why.

If “Here it comes” is the set-up, no doubt Kaptchuk also fantasizes that the following paragraph is what arrives after he warns skeptics, “It’s coming through now”:

As it turns out, placebos can work even when patients know they are getting a placebo. In 2010 my colleagues and I published a provocative study showing that patients with irritable bowel syndrome who were treated with what we call open-label placebos — as in, we gave them dummy pills and told them so — reported more symptom relief compared with patients who didn’t receive placebos. (These placebos were given with transparency and informed consent.) In another blow to the concept that concealment is required for placebo effects, my team recently published a study comparing open-label placebos and double-blind placebos in irritable bowel syndrome and found no significant difference between the two. A medical myth was overthrown.

Nope. A medical myth was born, namely the myth that placebo effects do not require deception. What do I mean? Let’s go way, way back to 2010, which was the first time I ever wrote about the myth of “placebos without deception,” namely because that was when the first of Kaptchuk’s “placebos without deception” studies hit the news. The idea is that the “power of placebos” can be harnessed even if you tell the patient that they are receiving a placebo and that his study showed just that. However, as I pointed out at the time, that narrative is not…quite…correct. From the study itself, here’s how the subjects were recruited to test “open-label placebos” on irritable bowel syndrome:

Participants were recruited from advertisements for “a novel mind-body management study of IBS” in newspapers and fliers and from referrals from healthcare professionals. During the telephone screening, potential enrollees were told that participants would receive “either placebo (inert) pills, which were like sugar pills which had been shown to have self-healing properties” or no-treatment.

Before potential subjects were even randomized to different groups in the study, they were told about how “powerful” placebo effects can be:

Patients who gave informed consent and fulfilled the inclusion and exclusion criteria were randomized into two groups: 1) placebo pill twice daily or 2) no-treatment. Before randomization and during the screening, the placebo pills were truthfully described as inert or inactive pills, like sugar pills, without any medication in it. Additionally, patients were told that “placebo pills, something like sugar pills, have been shown in rigorous clinical testing to produce significant mind-body self-healing processes.” The patient-provider relationship and contact time was similar in both groups. Study visits occurred at baseline (Day 1), midpoint (Day 11) and completion (Day 21). Assessment questionnaires were completed by patients with the assistance of a blinded assessor at study visits.

As I pointed out at the time, not only did Kaptchuk et al deceive their subjects to trigger placebo effects, but they might very well have specifically attracted patients more prone to believing that the power of “mind-body” interactions. While it is true that patients were informed that they were receiving a placebo, that knowledge was tainted by what the investigators told them about what the placebo pills could do. After all, investigators told subjects in the placebo group that science says that the placebo pills they would take were capable of activating some sort of powerful “mind-body” healing process. I pointed out that in most clinical trials, investigators tell subjects that they will be randomized to receive either the medicine being tested or a sugar pill (i.e., placebo). This, patients are told, means that they have a 50-50 chance of getting a real medicine and a 50-50 chance of receiving the placebo. In explaining this, investigators in general make no claim that that the placebo pill has any effect whatsoever and, in fact, are explicitly told that it does not. In contrast, Kaptchuk et al explicitly deceived their subjects for purposes of the study by telling them that the sugar pill activated some sort of mind-body woo that would make them feel better. True, they also told the subjects that they didn’t have to believe in mind-body interactions. But did it matter? I doubt it, because people with authority, whom patients tend to believe (namely doctors) also told subjects that evidence showed that these placebo pills activated some sort of “mind-body” mechanism that was described as “powerful.”

Back to the op-ed, in which Kaptchuk claims that many more studies since his original 2010 study show that he was correct:

Currently, more than a dozen randomized trials demonstrate that open-placebo treatment can reduce symptoms in many illnesses with primarily self-reported symptoms such as chronic low back pain, migraine, knee pain and more. These findings suggest that patients do not have to believe, expect or have faith in placebos to elicit placebo effects. So what’s happening?

I was curious about the specific studies to which Kaptchuk refers. This being an op-ed, of course, there are no links. (There wasn’t even a link to Kaptchuk’s original 2010 study! WTF, NYT?) I note that the 2010 study was not the only study by Kaptchuk about “placebos without deception,” either. He published one in 2014 of “open-label placebos” for migraines, which had exactly the same huge problem. Indeed, the script said things like, “Our second goal is to understand why placebo pills can also make you pain-free.” Note the assumption. The script didn’t say that placebo pills might decrease your pain. It said that they can make you “pain-free.” In 2016 he was co-author of a study on low back pain with—you guessed it!—the same problem but even worse. As I pointed out at the time, they used the same talking points from the IBS study, plus clips of happy study participants to prime the patients that placebo effects can be “powerful.” Again, people that patients tend to believe, doctors and nurses and other health care professionals, telling them that sugar pills could invoke powerful healing effects.

Are there any more recent studies? Doing a bit of PubMed searching, I found a number of studies of “open-label placebos,” most of which with Kaptchuk as a co-author. One thing that I’ve notices is that in the more recent articles it is much more difficult to find out exactly what subjects randomized to the open-label placebo arm are told. This study, for instance, says nothing more than that open-label placebo (OLP) recipients were told that they were receiving a “novel mind-body intervention” and that the “script for the OLP group is similar to our previous OLP.” Basically, perusing a number of these studies, I find that they all have the same problem in that they basically characterize placebos as being something like a “mind-body intervention” or being able to have significant effects on symptoms. In other words, “placebos without deception” are not. They’re just placebos, but with subtler deception. This 2023 study, which used open-label placebos with methadone treatment (!) for opioid use disorder, for example, even did this:

As in previous studies,²⁵ a script was used as a conversational guide to emphasize 4 points: (1) a brief description of the positive impact of placebo in RCTs; (2) the automatic nature of placebo responses, with a description appropriate for lay persons of the neurobiological and psychological (conditioning) mechanisms of associative learning; (3) the lack of a requirement of belief that the placebo would work; and (4) emphasis on the criticality of placebo consumption (Supplement 1 and eTable in Supplement 2). Participants then viewed a video of a television news piece that described scientific studies of OLP interventions to treat irritable bowel syndrome.⁴⁵

See what I mean? The researchers primed the open-label placebo group to believe that placebos work! Same as it ever was!

I’m going to conclude now as I concluded then by saying: There is no such thing as “placebos without deception.” However, because it is now widely agreed that deceiving patients is unethical except under very limited and specific circumstances, promoters of ineffective quackery that only appears to “work” because of placebo effects need to give the appearance of removing the deception in order to sell the narrative that placebos are valid medical treatments. That’s all it is, though. Appearance, nothing more. Placebos don’t work without deception, Ted Kaptchuk’s research notwithstanding, his op-ed in the NYT notwithstanding.

Although I believe, as Steve Novella does, that Ted Kaptchuk is well-meaning, but misguided—e.g., a true believer—the placebo narrative that he is promoting is harmful. I also believe that some of the other people promoting the placebo narrative are less well-meaning.